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FDA Resumes Planning & Conducting Domestic Surveillance Inspections

The U.S. Food & Drug Administration (FDA) has resumed planning and conducting domestic surveillance inspections across all commodities.

 
 

 

 #gmp #fda #regulations #fda21cfrpart820

https://www.fda.gov/news-events/press-announcements/fda-roundup-february-4-2022

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FDA Published Proposed Changes To 21 CFR Part 820

 

FDA published proposed changes to 21 CFR part 820 which seeks to harmonize the regulations with ISO 13485.

Public comment is due before May 24, 2022 related to the proposed changes.

Follow link below.

#gmp #fda #regulations #fda21cfrpart820 #iso13485

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AAOS 2022 Annual Meeting, March 22 -26 in Chicago

The AAOS 2022 annual meeting is back on the normal schedule taking place in Chicago, Illinois on March 22 through 26.  Hopefully attendance will be back to normal as well, allowing for more information exchange and networking.

 

Follow the link below for specific information direct from AAOS.

 

https://www.aaos.org/annual/

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Victoria Trafka, President Of EQS, Has A New Article Published Discussing The Benefits Of Protoyping Rapidly In ODT Magazine

 

Engineering & Quality Solutions, Inc's president and principal engineer, Victoria Trafka, authored a new article for Orthopedic & Design Technology magazine.  The article is titled "Intelligent Iteration: The Benefits of Prototyping Rapidly" and discusses the benefits and reasons for utilizing quick prototypes during all phases of product design for medical devices.

 

https://www.odtmag.com/issues/2021-03-01/view_columns/intelligent-iteration-the-benefits-of-prototyping-rapidly/?widget=listSection

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President Of EQS Honored To Have Article Published In Industry Magazine

Engineering & Quality Solutions, Inc"s president and principal engineer, Victoria Trafka, authored an article recently published in Orthopedic & Design Technology magazine.  The article is titled "Five Reasons For The Small World Of Orthopedic Product Development" and explores why product development engineers in the orthopedic and spine industry don't often cross over into other areas of medical device.

 

https://www.odtmag.com/issues/2019-11-01/view_columns/five-reasons-for-the-small-world-of-orthopedic-product-development/

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Attending the 2019 AAOS Annual Meeting in Las Vegas, Nevada

Engineering & Quality Solutions, Inc will have representatives attending the 2019 AAOS annual meeting March 12 – 16 in Las Vegas, Nevada.  This will be EQS's sixth year attending the AAOS annual meeting and we look forward to meeting with our current and prospective clients.

The AAOS annual meeting provides great opportunities to meet with peers, share perspectives keep track of industry trends and form successful partnerships. 

Please contact us to set up a time to meet in person and discuss how we can help you meet your medical device product development, quality system and training goals in 2019 and beyond!

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Pedicle screw usage to increase globally

Market research projects a 35% increase in revenue from the use of pedicle screws for the global market over the next 5 years.  See article below from ODT magazine. The consultants at Engineering & Quality Solutions have designed pedicle screw systems that have received FDA clearance in the past year for our clients. If you need product development help with a pedicle screw system please contact us to discuss how we may help you achieve your goals for your system.

https://www.odtmag.com/contents/view_breaking-news/2018-10-18/pedicle-screw-system-market-forecast-to-grow-to-7242-million-by-2023/48608

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Engineering & Quality Solutions, Inc. will be attending the North American Spine Society (NASS) 2018 annual

Engineering & Quality Solutions, Inc. will be attending the 2018 NASS annual meeting on September 26 & 27 in Los Angeles, CA.  We missed last year's meeting but are looking forward to meeting with our current and prospective clients, industry peers and contacts in Los Angeles.

Please contact us to set up a time to meet in person and discuss how we can help you meet your product development, Finite Element Analysis (FEA), Quality Management System (QMS) and training goals for 2018 and beyond!

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Attending AAOS 2017 Annual Meeting

Engineering & Quality Solutions will be attending the 2017 AAOS annual meeting March 14 – 17 in San Diego, CA.  This will be EQS's fourth year attending the AAOS annual meeting and we look forward to meeting with our current and prospective clients.

The AAOS annual meeting also provides great opportunities to meet with peers, share perspectives and form successful partnerships.  Please contact us to set up a time to meet in person and discuss how we can help you meet your medical device product development goals in 2017 and beyond!    

 

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